A randomized trial of the effect of ritonavir in maintaining quality of life in advanced HIV disease. Advanced HIV Disease Ritonavir Study Group.

Abstract

The aim of treatment for HIV disease is prolonging survival and improvement in health-related quality of life. Ritonavir is a potent, orally bioavailable HIV protease inhibitor with demonstrated impact on surrogate endpoints, AIDS-defining disease, and mortality. To evaluate the effect of ritonavir combined with reverse transcriptase inhibitor therapy on patient functioning and well-being. An international, multicenter randomized placebo-controlled clinical trial of ritonavir was conducted in HIV-infected patients with CD4 cell counts < or = 100 x 10(6)/l. A total of 1090 patients were randomized to ritonavir and continued treatment with as many as two nucleoside agents (n=543) or placebo and continued treatment with as many as two nucleoside agents (n=547). Health-related quality of life was measured at baseline and after 3 and 6 months of treatment using the Medical Outcomes Study HIV Health Survey (MOS-HIV) and HIV-related symptoms scale. MOS-HIV contains 10 subscales and two summary scores (physical health and mental health). The two treatment groups were comparable on baseline CD4 cell counts, demographic characteristics, and MOS-HIV and HIV symptom subscale scores. After 3 months, statistically significant differences (P < 0.03) favoring the ritonavir-treated patients were seen on the physical health summary, mental health summary, and general health perceptions, social function, mental health, and energy/fatigue subscales. After 6 months of ritonavir therapy, significant differences were observed on physical health and mental health summary scores (P < 0.001), and on measures of general health perceptions, physical function, role function, social function, cognitive function, mental health, health distress, energy/fatigue, and overall ratings of quality of life (P < 0.01). Ritonavir-treated patients reported fewer fever symptoms and neurologic symptoms than the placebo group after 6 months of treatment (P < 0.005). Ritonavir therapy, combined with other antiretroviral treatments, significantly contributes to maintenance of functioning and well-being over at least 6 months in patients with advanced HIV disease.